Belimumab in Remission of Vasculitis

Phase 1

Conditions: Wegener's granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis
MedDRA version: 14.1Level: PTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-004569-33-ES

Lead Sponsor: Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

-Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria.
-Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide.
-Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment.
-Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart.
-Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

-Pregnant or nursing.
-Receipt of a B cell targeted therapy (other than rituximab) at anytime
-Receipt of an investigational biological agent within the 60 days.
-Required management of acute or chronic infections within the past 60 days.
-Current drug or alcohol abuse or dependence.
-Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
-History of severe allergic reaction to contrast agents or biological medicines.